A Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of CKD-348(6)

• Sponsor: Chong Kun Dang Pharmaceutical (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06112678
• Collaborator: (none)
• Enrollment: 60
• Arms: 2
• Anticipated Duration (Months): 2.6

Study Details

Study Description

Brief Summary

A phase I clinical trial to evaluate the tolerability and the pharmacokinetics of CKD-348(6).

Condition or Disease	Intervention/Treatment	Phase
Hypertension; Dyslipidemias	Drug: CKD-348(6); Drug: CKD-828, D097, D337	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase I Clinical Trial to Evaluate the Tolerability and the Pharmacokinetics of CKD-348(6) Compared With Co-administration of CKD-828, D097, and D337 in Healthy Adult Volunteers
• Anticipated Study Start Date: Dec 8, 2023
• Anticipated Primary Completion Date: Feb 19, 2024
• Anticipated Study Completion Date: Feb 25, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sequence 1 Period 1: CKD-828, D097, D337- A single oral dose of 3 tablets under fasting condition Period 2: CKD-348(6) - A single oral dose of 1 tablet under fasting condition Period 3: CKD-828, D097, D337- A single oral dose of 3 tablets under fasting condition Period 4: CKD-348(6) - A single oral dose of 1 tablet under fasting condition	Drug: CKD-348(6); QD, PO; Drug: CKD-828, D097, D337; QD, PO
Experimental: Sequence 2 Period 1: CKD-348(6) - A single oral dose of 1 tablet under fasting condition Period 2: CKD-828, D097, D337- A single oral dose of 3 tablets under fasting condition Period 3: CKD-348(6) - A single oral dose of 1 tablet under fasting condition Period 4: CKD-828, D097, D337- A single oral dose of 3 tablets under fasting condition	Drug: CKD-348(6); QD, PO; Drug: CKD-828, D097, D337; QD, PO

Outcome Measures

Primary Outcome Measures

1. AUCt of CKD-348(6) [Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours]

   AUCt: Area under the concentration-time curve from time zero to time

2. Cmax of CKD-348(6) [Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours]

   Cmax: Maximum plasma concentration of the drug

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Healthy adult volunteers aged ≥ 19 years.

2. Body weight ≥55kg with calculated body mass index (BMI) of 18 to 30 kg/m2

3. Those who meet the blood pressure criteria during screening tests:

• Systolic Blood Pressure: 90 to 139 mmHg

• Diastolic Blood Pressure: 60 to 89 mmHg

1. Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings.

2. Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serology, urology) and ECG results at screening.

3. Those who agree to contraception during the participation of clinical trial.

4. Those who voluntarily decide to participate and agree to comply with the cautions after fully understand the detailed description of this clinical trial.

Exclusion Criteria:

1. Those who received investigational products or participated in bioequivalence tests within 6 months before the first administration of clinical trial drugs.

2. Those who take barbiturate and any related drugs which may cause induction or inhibition of drug metabolism within 1 month and those who take drug could affect to clinical trial within 10 days before the first administration of investigational products.

3. Those who donated whole blood or apheresis within 8 weeks or 4 weeks respectfully, or received blood transfusion within a month.

4. Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery.

5. Those who exceed an alcohol and cigarette consumption criteria write below within 1 month before the first administration of investigational products.

• Alcohol: Man - 21 glasses/week, Woman - 14 glasses/week (1glass: Soju 50mL, Wine 30mL, or beer 250mL)

• Smoking: 20 cigarettes/day

1. Those who have any history of diabetic mellitus, nephropathy, biliary obstruction, shock, angioedema, cardiac insufficiency, dihydropyridine sensitivity, unstable angina, hypothyroidism and hypersensitive to Sunset yellow FCF.

2. Those who have genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption.

3. Those who are deemed insufficient to participate in this clinical trial by investigators.

4. Woman who are pregnant or breastfeeding.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Chong Kun Dang Pharmaceutical

Investigators

• Principal Investigator: Seung-Hyun Kang, M.D., Ph.D, H Plus Yangji Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chong Kun Dang Pharmaceutical
• ClinicalTrials.gov Identifier: NCT06112678
• Other Study ID Numbers: A86_13BE2314
• First Posted: Nov 1, 2023
• Last Update Posted: Nov 1, 2023
• Last Verified: Oct 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dyslipidemias

Study Results

No Results Posted as of Nov 1, 2023